Device for the Removal of Thrombi

ABSTRACT

The invention relates to a device for the removal of foreign bodies and thrombi from body cavities and blood vessels using a guide wire provided with a distal element with said distal element being provided with an orthogonal structure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of PCT/EP2005/009057, filed Aug. 22,2005, which claims priority from Germany Application No. 10 2004 040868.8, filed Aug. 23, 2004, all of which are hereby incorporated hereinby reference.

BACKGROUND OF THE INVENTION

The invention relates to a device for the removal of foreign bodies andthrombi from body cavities and blood vessels using a guide wire providedwith a distal element. Said distal element is non-detachably connectedwith the guide wire.

The invention, furthermore, relates to a combination comprising such adevice and a cage element.

Thromboembolic diseases such as cardiac infarction, pulmonary embolism,peripheral thrombosis, organ embolisms etc. are typically caused by athromboembolism (hereinafter for short thromb or thrombus), i.e. avisco-elastic blood clot comprising platelets, fibrinogen, coagulationfactors etc. forming in a blood vessel which it obstructs either whollyor in part. The obstruction of organ arteries also leads to supply ofoxygen and nutrients to the associated tissue being interrupted. Thedisorder of the functional metabolism linked with functional losses isclosely followed by a failure of the structural metabolism resulting inthe relevant tissue becoming destroyed (infarction). Organs mostfrequently affected in this way are the heart and the brain.Nevertheless, the arteries of the limbs as well as pulmonary arteriesare also impaired.

Venous thromboses and thromboembolic occlusions are frequently occurringin the leg and pelvic veins. The disease pattern of the thromboticocclusion of an intracranial sinus may lead to severe intracerebralhemorrhage due to a failure of venous drainage of brain tissue.

In view of the severity of the disease patterns associated withthromboembolism and the prevalence rate of such diseases varioustechniques have been developed aimed at dissolving or removing thrombi.

It is known in this context to treat such patients with thrombolyticagents such as streptokinase or urokinase or anticoagulants intended toachieve thrombolysis or limit the growth of thrombi. Since treatmentmethods of this kind are usually very time consuming they are frequentlycombined with invasions aimed at reducing the size of or removing thethrombus or embolus mechanically.

Aside from open surgical operations prior art techniques more and moreembrace the use of transluminal or endovascular, catheter-guidedinterventional therapy methods because these are of less invasivenature. It is thus known to remove the thrombus from the patient's bodyby means of vacuum producing suction catheters or mechanically usingcatheters provided with capturing cages, helixes, hooks or similarelements; refer to U.S. Pat. No. 6,245,089 B1, U.S. Pat. No. 5,171,233A1, Thomas E. Mayer et al., Stroke 2002 (9), 2232.

Disadvantages associated with the known transluminal devices are thatwith said devices it is often impossible to remove the thromb completelyand, moreover, there is a risk of the thromb or fragments of it beingreleased into the blood stream thus passing on to vessels of smallerlumen which are more difficult to reach and treated. Furthermore, due totheir size and/or low flexibility the devices known from prior art areonly inadequately suited for the removal of thrombi from greatlyconvoluted vessels or those of particularly small lumen such as those inthe brain.

From US 2002/0049452 a device with a catheter is known for the removalof thrombi to which distal end capture arms made of shape-memorymaterial are attached which in their compressed state rest against thecatheter and when expanded extend radially from the catheter outwards.When in expanded position which is caused by the body temperature thecapture arms are intended to get caught in the thrombus and then retractit out of the blood vessel as the catheter is pulled back into anothercatheter. The drawback associated with this device is, however, that inorder to cool and thus keep the capture arms below transformationtemperature before they are released into the blood stream it musteither be moved behind the thrombus in a secondary catheter which bringsabout the cooling effect or inside the catheter provided with thecapture arms a heating system has to be arranged that enables thetransformation temperature to be attained when the thrombus has beenreached. Not only are the design requirements of this configuration veryhigh and thus prone to disturbances it is also the sheer physical sizeof this device that rules out a treatment of vessels having aparticularly small lumen.

In view of the disadvantages of these prior art devices it is thus theobject of the invention to provide a device for the removal of foreignbodies and thrombi from body cavities and blood vessels which alleviatesthe surgical risk existing when removing thrombi and allows thetreatment of vessels of especially small lumen.

BRIEF SUMMARY OF THE INVENTION

According to the invention this objective is reached by providing adevice of the kind first mentioned above which is characterized in thatthe distal element has a primarily orthogonal structure. Preferably, theorthogonal structure consists of a multitude of fibers or bristles whichcan be arranged either individually or in bundles.

The invention is based on findings by the inventors proving that the useof such a simply designed device capable of being made of particularlysmall size is suited to recover thrombi also from vessels having anespecially small lumen. The guide wire designed as insertion aid enablesthe device to be easily moved also into small-lumen and convolutedvessel segments and keeps the overall diameter of it small, but inparticular the device diameter that cannot be varied (the diameter whichis brought about by the fibers may be variable in as much as these areflexible so that even constricted vessel routes can be passed through).The fibers/bristles are suited to capture and stabilize a thrombus,especially if they are made of or finished with thrombogeneousmaterials.

It goes without saying that guide wire and distal element arenon-detachably connected with each other.

The device is transferred to the application site with the aid of asmall-lumen micro-catheter. The device situated inside themicro-catheter may either be 1) first maneuvered to the distal locationof the thrombus and then retracted, 2) released from the micro-catheterin the area of the thrombus, or 3) pushed out of the micro-catheter at apoint proximally to the thrombus and then penetrate the thrombusanterogradedly. When moving the device forward the flexible fibers arepressed onto the distal element due to the mechanical resistance inproximal direction. When being retracted, however, they are positioneduprightly, catch hold of the thrombus and thus assist its recovery intoa catheter larger than the originally used micro-catheter. In accordancewith the state of the art a guiding catheter will be used by means ofwhich the main vessel is probed. Through this guide catheter amicro-catheter will be inserted coaxially that serves to introduce thesaid device and transfer it to the target region. The thrombus thussecured via said device will then preferably be retracted into the guidecatheter and contained in this catheter eliminated from the body.

It is understood that for the intended purpose the fibers/bristles musthave adequate stiffness but at the same time must be flexible orbendable enough so that they can be passed through a catheter and do notdamage the vessel walls.

The fibers may consist of a natural substance, polymer material, metal,ceramic material, glass or a combination thereof.

As per a preferred embodiment of the device the fibers consist of apolymer material.

Suitable materials in this respect are primarily polyurethane,polyacrylics, polyester, polytetrafluoroethylene or polyethylene and,due to its peptide-like bond structure, most notably polyurethane andpolyamide which enable the thrombus to excellently attach or “adhere” tothe fibers.

Aside from polymer materials metals also well suited for the intendedpurpose. Suitable metallic materials for treatment purposes are allmetals that do not have detrimental effects on the patients. Especiallysuited for the described purpose are stainless steel fibers made ofmetal alloys having shape-memory properties such as for example nitinolfibers. Fibers made of shape-memory materials offer the advantage thatwhen under the external strain exerted by a micro-catheter they areinitially shaped to fit the distal element closely and having beenreleased from the micro-catheter assume a second orthogonal shapeallowing them to stick out freely. Furthermore, gold and platinum aresuitable materials as well.

Ceramic material and fiber glass also suit the intended purpose withcarbon fibers to be counted among the group of ceramic materials.

The fibers or bristles to be used according to the invention projectfrom the distal element preferably at an angle of approx. 90°. However,an orthogonal structure within the scope of the invention is to beunderstood as any structure that does not extend parallelly to thedistal element, i.e. forms any optional angle with said distal element.

It is to be ensured that the fibers used in accordance with theinvention have adequate stiffness in order to capture and attach to athrombus. Such stiffness, however, must not lead to the fibers orbristles being able to damage the vessel walls.

The fibers or bristles are connected with the distal element in a mannerknown per se, for example, as is known from the fabrication offiber-equipped embolization spirals. This may be achieved throughentwinement with the distal element, by gluing, welding or any othersuitable fastening method.

Particularly suitable for the treatment of vessels of especially smalllumen are fibers having a length of 0.5 to 6 and preferably 0.5 to 3 mmso that an outer diameter of 1 to maximum 12 mm of the fiber-carryingpart of the distal element is attained even when the bristles arearranged radially. For a particularly atraumatic treatment such outerdiameter should be slightly smaller than the inner diameter of therelevant blood vessel.

As per an expedient embodiment the fibers have an essentially straightshape.

In accordance with another expedient embodiment the fibers have ahook-shaped configuration with their hook-shaped ends advantageouslybeing bent in proximal direction so that when being inserted into theblood vessel they cannot impede the insertion process but serve toimprove thrombus anchoring during retraction from the blood vessel.Furthermore, crimpy or helix-shaped structures may be employed as well.As far as the fibers are intended and suited to be “glued” to a thrombusgood clinging properties and a large contact area are considered to bebeneficial.

As per an advantageous embodiment of the device the fibers or fiberbundles extend radially outward from the longitudinal axis of the distalelement. In this embodiment the fiber carrying portion of the distalelement is designed similar to a bottle brush.

In accordance with another variant the individual fibers or fiberbundles are arranged in rows. This means the fibers, basically, runparallel to each other in several direction so that fiber-free channelsare created between such fiber rows and the fiber bundle rows.

As per another advantageous design of the device the fibers are arrangedspirally along the longitudinal axis of the filament. This embodiment isespecially suited for “piercing” or penetrating into the thrombus as thefiber-carrying portion of the distal element works in the same way as acorkscrew if appropriately manipulated by the surgeon. The angle betweenthe fibers and the distal element preferably ranges between 45° and 105°with the value of 45° applying to the proximal alignment and that of105° to the distal alignment or orientation of the fibers.

Especially preferred is an angle of 90° maximum or slightly less than90° between the distal element and the longitudinal axis of the fibers.The embodiment providing for an angle of slightly less than 90° isparticularly atraumatic when moving into the vessel or through the tromband at the same time results in an especially effective anchoring withinthe thrombus when the element is pulled out of the blood vessel.

In accordance with an expedient embodiment of the device the fibersextend over a length of the distal element which ranges between 0.5 and5 cm.

To make sure the thrombus is sufficiently secured and the respectivestiffness is conducive to the element being capable of passing throughthe thrombus it is expedient if the fibers are arranged on the distalportion of the insertion aid with a density ranging between 20 and 100per cm.

Basically, the fibers may be secured to the insertion aid in anyconceivable manner that rules out their detachment. Especially suitedfor this purposes is a gluing method or mechanical connection. Forexample, a suitable gluing material is Permabond. As a mechanicalconnection method clamping onto the insertion aid is primarilyexpedient, especially if the fiber-carrying distal element has beendesigned in the form of a micro-coil or spiral.

Expediently, the guide wire is made of a medical stainless steel orshape-memory material, preferably nitinol.

It is, furthermore, expedient to provide a guide wire having an outerdiameter ranging between 0.2 and 0.4 preferably 0.22 and 0.27 mm.

Also considered expedient is a guide wire having a length of between 50and 180 cm.

The distal element may also consist of stainless steel or shape-memorymaterial, for example nitinol. However, the distal element is preferablymade of radiopaque material, for example a platinum alloy, or containssuch a material.

The distal element may be of elongated shape showing a primarilystraight configuration, but to satisfy specific applications may alsohave a bent structure, for instance incorporating a J-shaped bent tip, acorkscrew-like structure or similar shape.

In accordance with an advantageous embodiment the distal element isprovided with at least one radiopaque marker.

Moreover, it is considered advantageous if the tip of the distal elementis designed so as to be atraumatic, i.e. is rounded off for example.

As per a particularly preferred embodiment of the device the fibers arecoated. For example, this coating may be a neutral one consisting ofParylene or Teflon®, but may also comprise collagen or may be a coatingof a material conducive to blood coagulation, preferably having one orseveral coagulation factors. This embodiment serves to strengthen theanchorage of the fibers inside the thrombus and alleviates the risk ofthe thrombus disintegrating leaving fragments of the thrombus in theblood vessel or allowing them to be released in the blood stream.

Surprisingly, it has been found that a thrombogeneous finishing of theorthogonal structure and in particular of the fibers resulted in asignificant stabilization of the inventive device. In this context it isleft to the surgeon to bring the inventive device into contact with thethrombus and maintain this contact for a certain period of time thusallowing the thrombogeneous elements to promote an “adherence” to thedevice. Such an “adherence” to thrombogeneous fibers/bristles isachieved after a relatively short period, even within a few minutes attimes. Not only does this preclude the disintegration of the thrombus asit is encountered with many commercially available retrievers, also theretraction of the thrombus and its extraction from the vascular systemis facilitated in this manner. Especially suited thrombogeneousmaterials and coatings for this purpose are known from literature tothose skilled in the art.

Particularly suited to this end are one or several of the factorsfibrin, thrombin, factor XIII and/or factor VIII.

It may, moreover, be expedient to also provide the portion of the distalelement with the above described coagulation promoting coating materialthat carries the orthogonal structure.

In accordance with another advantageous embodiment the inventive deviceis provided at its distal element with an oblong cage structure suitedto be flatly collapsible under the external strain exerted by a catheterand capable of unfolding to its full cage structure when said externalstrain is omitted. The design of such cages is sufficiently known tocompetent persons skilled in the art. The cage structure may be helpfulin the extraction of the thrombus.

Generally, the cage structure has an oblong, ship-like structure of alength ranging between 5 and 50 mm with a diameter of between 2 and 6mm. Half of the cage may be covered with a net structure and/or the cagemay be provided with peripheral, in particular longitudinally extendingreinforcing wires or braces.

In accordance with an expedient embodiment of the inventive combinationalso the cage structure is provided with at least one radiopaque marker.Beneficially, this marker is arranged at the distal end of the cagestructure.

It is also considered expedient for the cage structure to be made ofshape-memory material, preferably nitinol, which enables said structureto be transported in folded-up condition in a micro-catheter and tounfold when being released from the micro-catheter.

An especially preferred embodiment of such a cage structure has three ormore braces, in particular four braces, spaced at 90° in relation toeach other. These braces may be connected with each other by means of anet structure, however this is not absolutely required. Preferably, thebraces consist of a shape-memory material, for example nitinol.

The orthogonal structure of the distal element in this case preferablyextends centrally inside the cage structure. Nevertheless, variants arealso conceivable in which it may be reasonable to have the bracesarranged asymmetrically and/or provide for a non-central arrangement ofthe distal element, for example in cases where it is necessary to passaround the thrombus on one side in order to move it into the cagestructure.

Generally speaking, the cage structure normally folds up under theinfluence of the external constraint caused by a catheter whenstretching of the structures in the area of the distal element takesplace. To counteract this stretching or facilitate contraction when thedistal element is released from the guiding catheter is is deemedreasonable to design the distal element in the area of the cage suchthat it is movable allowing it to follow this stretching/contractionmovements. For this purpose the distal element is provided with a guideinside of which a proximal and a distal wire element of this distalelement are capable of moving in axial direction. Such a guideexpediently consists of a helically wound wire which allows for a hollowspace forming inside of it. Such a wire may, for example, be made of aradiopaque metal, for example platinum or a platinum alloy.

In the event of this embodiment the orthogonal structure in the form offibers or fiber bundles is expediently attached to the guide, i.e. gluedto or molten onto the guide or wound around the wire coils.

To enable a compulsory straightening up of the fibers or fiber bundlessaid fibers or fiber bundles may be attached to the braces of the cagestructure, for example by gluing, melting on or, alternatively, bydesigning the individual fibers to form loops which are placed aroundthe braces. When the braces are unfolded upon being released from acatheter the fibers or fiber bundles straighten up in a compulsorymanner.

As per another beneficial embodiment the braces of the cage structureare arranged in a helical fashion, i.e. starting point and end point onthe distal element are offset against each other by a certain angle,ranging for example between 45° and 180°, preferably by approx. 90°.Such a helical line arrangement allows a thrombus adhering to a vesselwall to be sheared or cut off when the cage structure is moved forwardwithout the necessity of having to turn to device.

In accordance with another variant the braces extend along a wave linewith a lateral deflection of between 45° and approx. 90°, i.e. thebraces at first extend in lateral direction until they have reached forinstance a point offset by 90° to the starting point on the distalelement and then along the second half of their length extend back tothe starting point.

As described above with respect to the bristles/fibers the cagestructure may consist of the same thrombogeneous materials or providedwith a finish of said thrombogeneous material.

Eventually, the invention also relates to the combination of the devicewith a guide and/or micro-catheter in which the device is maneuvered tothe application site and when filled with the thrombus removed from theblood vessel system. It may be expedient to additionally design thecatheter as an aspiration catheter by means of which micro-catheters canbe withdrawn or extracted.

BRIEF DESCRIPTION OF THE DRAWINGS

Further elucidation of the invention is provided by way of examplesthrough the following figures, where

FIG. 1 is the enlarged representation of an inventive device designed inthe form of a bottle brush;

FIG. 2 is the representation of the combination of an inventive devicewith a device carrying a retrieval cage shown as an amplified view;

FIG. 3 shows an enlarged representation of an inventive device withadditional retrieval cage;

FIG. 4 shows an amplified representation of a guide wire with retrievalcage attached to it;

FIG. 5 shows another embodiment of an inventive device viewed from theside, from the front end and in collapsed condition;

FIG. 6 shows extension variants of the braces of the cage structureaccording to FIG. 5;

FIG. 7 shows a variant for the connection of the orthogonal structurewith the braces illustrated in FIG. 5;

FIG. 8 is another variant of the design of a retrieval cage of theinventive device;

FIG. 9 illustrates a retrieval cage wired with nylon fibers inaccordance with the invention;

FIG. 10 is another variant of the inventive design with a retrieval cageprovided with spacer elements;

FIG. 11 shows another embodiment of an inventive device provided with afirmly secured polymer skin; and

FIG. 12 shows another embodiment providing for cross-over braces of theretrieval cage of the inventive device.

DETAILED DESCRIPTION OF THE INVENTION

The inventive device 1 shown in FIG. 1 is provided at the distal end ofthe guide wire 2 made of nitinol and having a diameter of 0.254 mm withfunctional unit 3 intended for the retrieval of thrombi. Functional unit3 is provided with polyamide bristles 4 having a length of 2 mm andbeing attached radially onto guide wire 2. The diameter of functionalunit 3 is thus 4 mm and is particularly suited for the retrieval ofthrombi out of vessels having an inner diameter ranging approx. between4.5 and 5 mm. In the area where the bristles are situated guide wire 2is designed as a platinum micro-coil 5; this embodiment is especiallyflexible and at the same time serves as radiopaque marker to enable theplacement to be performed under radiographic observance. The distal tipof the micro-coil has been rounded off to render it particularlyatraumatic. Bristles 4 are mechanically clamped into the coil with onefiber each forming two bristles 4, having a length slightly more thandouble bristle length and extending across the coil so that two oppositebristles are formed which project from the coil. The bristles are coatedwith fibrin to ensure a good adherence of the thrombus to device 1.

Device 1 with its distal portion forward is pushed through the bloodvessel system into the blood vessel obstructed by the thrombus makinguse of a micro-catheter 6 having, for example, an inner diameter of 0.67mm. At the application site the device is correctly positioned underradiographic control and for that purpose moved out of the catheter,moved past the thrombus or through it by employing customarystate-of-the art methods. Through mechanical resistance bristles 4 areoriented in proximal direction at that time. Subsequently, the device 1is retracted in proximal direction so that the bristles assume anupright position, hook themselves into the thrombus and carry it intothe micro-catheter 6 by means of which it is eliminated from the bloodvessel system.

FIG. 2 illustrates the combination of an inventive device 1 providedwith functional unit 3 designed in the form of a bottle brush with adevice carrying a thrombus retrieval cage 7 consisting of braces 12.Both devices are provided with separate guide wires 2/2′ which, however,are not shown separately in the figure. The retrieval cage 7 is made ofnitinol and may be provided with a mesh covering (not shown in thefigure) distributed over its body. On the proximal and distal ends ofthe cage there are, for radiological monitoring purposes, radiopaquemarkers 9 made of platinum on guide wire 2′ of the device carrying theretrieval cage 7. Through the mechanical constraint exerted by themicro-catheter 6 retrieval cage 7 is kept in compressed condition whilebeing transported inside said catheter. After it has been pushed out ofmicro-catheter 6 and with the constraint eliminated it passes through astress-induced martensitic transformation and assumes its expandedconfiguration as shown in FIG. 2. In this configuration is has an outerdiameter that expediently corresponds mainly with that of functionalunit 3 of the device 1 or is slightly larger but still smaller than theinner diameter of the vessel to be treated. After cage 7 has been pushedout of micro-catheter 6 the distal area of device 1 guided inside thesame micro-catheter 6 is also moved out of the micro-catheter 6 throughcage 7 and into the thrombus. Following this, the device 1 together withthe thrombus located inside functional unit 3 is drawn into cage 7. Assoon as functional unit 3 and thrombus are situated in cage 7 bothdevices are retracted in unison into micro-catheter 6 with relativemovements of both devices in relation to each other to be avoided. Thecage in this case serves as an additional safeguard preventing thethrombus or fragments thereof from becoming detached from the device 1.

Another embodiment of the inventive device 1 including additionalretrieval cage 7′ is shown in FIG. 3 with said cage being attached tothe same guide wire which holds functional unit 3 designed in the formof a bottle brush featuring radially arranged bristles 4. Said guidewire 2 is entirely made of nitinol. In the area of the functional unit 3the bristles 4 are attached to said wire by gluing using Permabond. Thedevice 1′ is provided with two radiopaque markers 9/9′ made of platinum,said markers being located at the proximal and distal ends of cage 7′.The retrieval cage has a mesh structure narrowing from proximal todistal so as to provide increased safety against losing thrombusfragments that may slip out of the cage when the device 1′ is retractedout of the blood vessel. A greater mesh size in the proximal area of thecage facilitates the retraction of the cage into the catheter with thestructures collapsing and containing the thrombus which additionally issecured inside the cage by action of the bristles.

It is to be noted in this context that the device in accordance with theinvention also lends itself to the extraction of foreign bodies, forexample embolization spirals or stents.

FIG. 4 shows a simple embodiment of the retrieval cage as has beendescribed above in conjunction with FIG. 3. The retrieval cage in thiscase consists of an external wire structure and reinforcing braces madeof a shape-memory material, such as for example nitinol, as well as anet arranged therein with said net consisting of a thrombogeneousmaterial, for example polyurethane, polyamide or similar material. Thematerials may also be provided with a coating. Having been released fromthe micro-catheter the cage structure unfolds and after the thrombus hasbeen retrieved and the cage is retracted into the micro-catheter iscapable of folding up again which is facilitated by the shape of theframe tapering in the proximal direction.

In the representation the wire framing has reference number 12, the netstructure has been identified by 11 whereas the reinforcing braces aregiven reference number 10.

FIG. 5 shows another variant of a device according to the invention forthe extraction of thrombi including guide wire or pusher wire 2connecting to the cage structure 7 being provided with a total of fourbraces 12 equally arranged over the circumference. The braces 12 consistof nitinol and, accordingly, have shape-memory properties. They extendfrom proximal marker 9 to marker 9′ said markers also being designed asa sleeve accommodating and combining the braces 12 forming the cagestructure. Shown in the figure is a cage structure comprising fourbraces offset against each other by 90°; other structures having less ormore braces of equal or irregular distribution and spacing over thecircumference may be used without problems. At marker 9 the distallyextending guide wire 2 becomes proximal wire 21 which in turn projectsinto guide element 22 of helically wound shape. Guide element 22 is madeof a platinum/iridium wire which has marking characteristics. At thedistal end of this guide 22 there is a second wire segment 23terminating in distal marker 9′. The distal wire segment 23 may bepermanently connected with the platinum guide 22 or guided inside of it.At the distal end of distal marker 9′ there is an atraumaticallydesigned tip 14 having the shape of a platinum or plastic hemisphere.

The distal element of this device consists of the proximal wire element21, guide 22, distal wire element 23 as well as the fibers or bristlebundles 4 attached to guide 22. The fiber bundles may be interlaced inthe wound wire element 22 or glued to it, or melted on it, if thoughtexpedient. FIG. 5 b shows the representation 5 a viewed from the distalmarker 9′ with centrically arranged atraumatic tip 14, braces 12 spacedat 90° intervals as well as well as fiber bundles 4 arranged around thebraces. In the configuration shown the fiber bundles are arranged infour stages and in alignment with each other.

FIG. 5 c shows the device illustrated in FIG. 5 a drawn into amicro-catheter 6 with elongated braces 12 and fibers 4 in retroflexedposition. In comparison with FIG. 5 a it is noticeable that the spacingbetween markers 9 and 9′ has become greater due to the elongation of thebraces 12.

In FIG. 6 two variants of a brace configuration are illustrated thatdeviate from the device in FIG. 5. In relation to the guide wire 2 andits distal continuation in the distal element 3 the configuration of abrace 12 is as shown with starting and end points of the wire runstaggered by 90° and the run of brace 12 extending towards the viewer.When viewing the illustration in the direction of the guide wire 2 thebrace 12 approximately performs a three-quarter turn in which connectionit is to be noted that the spacing between starting and end points isgoverned by length 7 of the cage structure.

Such a configuration of brace 12 allows the attending physician to shearoff a thrombus adhering to the vessel wall by carefully advancing theretrieval device.

FIG. 6 b shows another variant in which brace 12 extending towards theviewer initially performs a 90° turn where it reaches the point farthestaway from the guide wire roughly in the middle at M and then extendsback so that starting and end points are not offset against each other.This variant helps to avoid rotating movements and stresses on thethrombus when pull or thrust forces are exerted and at the same timeserves length buffering purposes.

FIG. 7 is a schematic representation of a variant by means of which thefibers 4 are connected with the braces 12 of the cage structure. Thefibers 4 start out from the coils of the guides 22, extend around abrace 12 and run back to the guide 22. When the cage structure unfoldsafter it has been released from a catheter a compulsory straightening upof fibers 4 takes place orthogonally to the run of guide 22.

FIGS. 8 show three different variants of an embodiment in which cage 7has been provided with additional braces or loops 8 at its distal end sothat a more densely configured structure of said distal end is achieved.For the sake of clarity and to make the underlying principle clear thecage representations only show two of a minimum of four braces 12.Moreover, the central elements of the “bottle brush” have been omittedentirely or to some extent.

FIG. 8 a shows the cage with braces 12 and its markers 9′ (distal) and 9(proximal). The guide wire 2 extends through the proximal marker 9 andpasses on into guide element 22. An oval ring 15 is attached to thebraces 12 with loop-shaped braces 8 being passed around said ring. Theseloop-shaped braces 8 start and end within the marking spiral 9′ whichalso serves as a sleeve for the braces 12 and 8 with said braces 8 beingloosely passed around ring 15. The oval configuration of the ring 15providing for the attachment points at braces 12 not being located onidentical levels enables the braces or loops 8 to easily adapt to theelongation situation of the cage inside and external to a catheter.

It is understood that in this and in other embodiments the markingspirals 9 and 9′ each have a dual function. On the one hand they serveas markers and on the other as sleeves for the connection of braces 8and 12 that are attached within and, if thought expedient, to thissleeve in a form-closed fashion or otherwise by bonding or fusing.

FIG. 8 b shows another embodiment in which the oval ring 15 extendsthrough lugs 14 arranged on the braces 12. Otherwise, this embodimentcoincides with that shown in FIG. 8 a.

In FIG. 8 c the ring 15 has been omitted altogether and loops 10 aredirectly connected with the lugs 14 provided on braces 12. It isunderstood in this context that the loops or braces 10 adapt themselvesto the cage structure, i.e. are of a configuration that corresponds tothat of the braces 12.

Further embodiments are illustrated in FIG. 9 where for the sake ofsimplicity only part of the braces are shown. The orthogonal structurehas not be shown in FIG. 9 a and FIG. 9 b.

FIG. 9 a shows a cage structure according to the invention in which theguide wire 2 extends through the proximal marker 9, passes on into guide22 and terminates in the distal marker 9′. Over a stretch of theirlength, particularly in the distal area, the braces 12 are provided witha winding or lining consisting of marking spirals made of aplatinum-iridium alloy as well as with a winding made of fiber material16 extending from the distal end and covering part of the length of thebraces 12. This winding may, for instance, consist of nylon fibers whichare pressed into the gaps between the individual coils of the markingspiral and is preferably applied in one pass, i.e. the entire windingconsists of a single filament. Pressing the filament into or gluing itonto the marking spirals 18 arranged on braces 12 at the same timeresults in fixing the braces in position so that their spacing relativeto each other is maintained.

FIG. 9 b represents another variant in which a nylon filament is woundaround a cage having been provided with a total of seven braces 12. Thewinding cover that, same as described in FIG. 9 a, only extends overpart of the cage, i.e. over the distal area, in this case has beenplaced in alternating fashion inside and outside around the braces 12and has an even improved fixation effect. The reference number 22identifies the central guide surrounding the individual elements of theguide wire 2. Braces 12 have been provided with a marking spiral 18.

An even more stringent fixation of the braces 12 in their positionrelative to each other is shown in FIG. 10 a which illustrates twobraces 12 connected with each other by means of a flexible clip 19. Theconnection with this “vee-shaped” element may be brought about either bya form-closed method or by bonding (welding, gluing). Braces 12 in thiscase as well are lined with marking spirals made of a platinum-iridiumalloy which may be employed to secure the clip 19 in position.

In FIG. 10 b the embodiment depicted in FIG. 10 a is shown as across-sectional view of a complete cage. The individual braces 12, sixin this case, are connected with each other via the clips 19. Thefilaments 4 of the orthogonal structure extend between the central guide22 which has been designed as a spiral and braces 12 with said filamentsbeing placed in loops around the relevant longitudinal elements 12 and22.

FIG. 11 illustrates another variant that is related to the variantsprovided with the net structures described in FIGS. 3 and 4. In thiscase the cage is covered in its distal area with a polymer skin 17consisting for example of expanded PTFE so that the distal end of thecage forms a bag-like structure. The polymer skin extends from thedistal tip of the cage along the braces on to a desired position, forexample to roughly the middle of the cage.

In this case the proximal edge of the polymer skin preferably has awave-like contour so that the edge line between two braces is moreclosely located distally (a) than the area situated at the bracesthemselves (b). The braces may be embedded into the polymer skin orattached to it by adhesives.

FIG. 11 b shows another variant in which the edge of the polymer skinhas a modified contour in comparison with that depicted in FIG. 11 awith said edge at braces 12 being arranged closer to the distal end.This enables the braces to be extensively fixed in relation to eachother. Between the braces the polymer skin is recessed in proximaldirection. This edge structure may be stabilized by means of aconnecting brace or clip 17 as described in FIG. 10 a.

FIG. 12 finally shows a special configuration of the braces 12 extendingfrom the distal to the proximal end and being offset against each otherby 180°, i.e. extend from the upper side of a cage structure to thelower side of it. The arrangement of a pair of braces in relation toguide 22 is illustrated in FIG. 12 b by way of a pair of braces 12 and12′. It shall be understood that the cage structure which in this caseis rather a double-cage structure comprises at least two, but better atleast three pairs of braces equally spaced over the circumference.

This configuration enables forces exerted radially in the braces to beutilized by transmitting them to the opposite side such that the cage onany account maintains its unfolded shape even if the nominal diametercannot be attained inside a narrow vessel. In particular, this isapplicable with respect to the guide 22 that enables the length to beappropriately varied.

It shall be understood that in the above description the terms “distal”and “proximal” relate to the attending physician. Accordingly, “distal”refers to the end of, for example, the cage or catheter situated awayfrom the attending physician.

1. Device for the removal of foreign bodies and thrombi from bodycavities and blood vessels using a guide wire provided with a distalelement, characterized in that, said distal element has an orthogonalstructure.
 2. Device in accordance with claim 1, characterized in thatthe orthogonal structure consists of fibers/bristles.
 3. Deviceaccording to claim 2, characterized in that the fibers or bristlesconsist of a polymer material.
 4. Device according to claims 2 or 3,characterized in that the fibers are made of polyurethane, polyamide,polyacrylics, polyester, polytetrafluoroethylene or polyalkylene. 5.Device according to claim 2, characterized in that the fibers orbristles are made of metal.
 6. Device according to claim 5,characterized in that the fibers or bristles consist of stainless steel,a metal having shape-memory characteristics, gold or platinum.
 7. Deviceaccording to claim 2, characterized in that the fibers or bristlesconsist of ceramic material, glass or a combination thereof or withmetal or plastic material.
 8. Device according to any one of the aboveclaims, characterized in that the fibers have a length of between 0.5and 6 mm and preferably between 1.2 and 3 mm.
 9. Device according to anyone of the above claims, characterized in that the fibers form an anglewith the distal element that ranges between 45° and 105°, preferably isapprox. 90°.
 10. Device according to any one of the above claims,characterized in that the fibers are arranged spirally along thelongitudinal axis of the distal element.
 11. Device according to any oneof the claims 1 to 9, characterized in that the fibers basically arealigned parallelly to each other in two or more directions.
 12. Deviceaccording to any one of the above claims, characterized in that thedistal element has been provided with a wire wound into a helicalconfiguration.
 13. Device according to any one of the above claims,characterized in that the distal element consists entirely or in part ofstainless steel or a metal having shape-memory properties.
 14. Deviceaccording to any one of the above claims, characterized in that thedistal element has been provided with at least one radiopaque marker.15. Device according to any one of the above claims, characterized inthat the orthogonal structure has been provided with a coating. 16.Device according to claim 15, characterized in that the coating consistsof Parylene or polytetrafluoroethylene.
 17. Device according to claim15, characterized in that the coating comprises collagen or a materialconducive to blood coagulation.
 18. Device according to claim 17,characterized in that the coating contains fibrin, thrombin, factor VIIIand/or factor XIIIa.
 19. Device according to any one of the aboveclaims, characterized in that said device has an oblong cage structuresuited to be flatly collapsible under the external strain exerted by amicro-catheter and capable of being transported inside themicro-catheter and unfolding to its full cage structure when saidexternal strain caused by the micro-catheter is omitted.
 20. Deviceaccording to claim 19, characterized in that the cage structure has beenprovided with three or more braces.
 21. Device according to claim 19 or20, characterized in that the braces are made of a shape-memorymaterial.
 22. Device according to claim 21, characterized in that thebraces consist of nitinol.
 23. Device according to any one of the claims19 to 22, characterized in that the orthogonal structure of the distalelement extends centrally in the cage structure.
 24. Device according toany one of the claims 19 to 23, characterized in that the distal elementof the guide wire is provided with a guide in the area of the cage inwhich a proximal wire element of the distal element is slidablyarranged.
 25. Device according to claim 24, characterized in that theguide is a wire of helically wound shape.
 26. Device according to claim25, characterized in that the helically wound wire consists of platinumor a platinum alloy.
 27. Device according to any one of the claims 24 to26, characterized in that the orthogonal structure consists of fibers orfiber bundles attached to the guide.
 28. Device according to claim 27,characterized in that the fibers or fiber bundles are attached to thebraces of the cage structure.
 29. Device according to claim 28,characterized in that the fibers or fiber bundles are attached to thebraces by way of gluing, melting-on or by means of a loop structure. 30.Device according to any one of the claims 19 to 29, characterized inthat the braces extend in the form of a helical line so that theirstarting point is offset by 45° to 180° in relation to their end point.31. Device according to any one of the claims 19 to 29, characterized inthat the braces extend in the form of a wave line with a lateraldeflection of between 45° and 90° with the starting point and end pointnot being offset against each other.
 32. Device according to any one ofthe claims 19 to 29, characterized in that the braces extend in aconfiguration offset by 180°.
 33. Device according to any one of theclaims 19 to 31, characterized in that the cage structure has beenprovided with a net structure.
 34. Device according to any one of theclaims 19 to 31, characterized in that the cage structure has beencovered distally with a polymer structure.
 35. Device according to anyone of the claims 1 to 23, characterized in that the distal element withits orthogonal structure and the cage structure are arranged on separateguide wires and are designed so as to be movable in relation to eachother.
 36. Device according to any one of the above claims, incombination with a guiding catheter and/or micro-catheter. 37.Combination according to claim 36, characterized in that theguiding/micro-catheter is designed as aspiration catheter.